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Spex

by Spex Ltd 1,000+ variants

Ref 0079-0004-000

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number94200517ARMTHIGHCOMBOPF Basic UDI-DI 09420051797680UDI-DIDate11 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Arm and Thigh Combination Support
Model / Reference
0079-0004-000
Primary DI / UDI-DI
09420051797680
Basic UDI-DI
94200517ARMTHIGHCOMBOPF
EMDN Code
Y122406 Belts, seats and armrests for wheelchairs
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
NZ-MF-000009327
Authorised representative
BEO MedConsulting Berlin GmbH DE-AR-000006764

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No